SOLICITATION NOTICE
B -- Evaluation of Long-Term Safety and Effectiveness of Joint Replacement Devices
- Notice Date
- 3/31/2009
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Field Finance & Acquisition Services, HFT-320, 3900 NCTR Road, Jefferson, Arkansas, 72079-9502
- ZIP Code
- 72079-9502
- Solicitation Number
- 09-222-SOL-00006
- Archive Date
- 4/29/2009
- Point of Contact
- Regina R. Williams, Phone: (870) 543-7012, Marcia O Park,, Phone: (870) 543-7405
- E-Mail Address
-
regina.williams@fda.hhs.gov, marcia.park@fda.hhs.gov
- Small Business Set-Aside
- N/A
- Description
- This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. The requirement will be awarded using Simplified Acquisition Procedures in accordance with FAR Part 13. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is 09-222-SOL-00006. This solicitation is issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-31, March 19, 2009. The associated North American Industry Classification System (NAICS) Code is 541990-All Other Professional, Scientific, and Technical Services and the size standard is $6.5 million. The Food and Drug Administration/Center for Devices and Radiological Health has a requirement for the following: Collaboration with entities that are collecting extensive information on artificial joint replacements with a response rate over 80% and a minimum of 300 participants included in their registry that have been followed for at least one (1) year. The proposed study would produce valid and precise estimates of device performance following the implantation of the device that would benefit decision-making of patients, clinicians and CDRH. Crucial variables include device survival and device related adverse events. OBJECTIVES: 1) Evaluate long-term safety and effectiveness of artificial joints through the use of registry data that includes adequate long-term follow-up information: Analysis of common factors associated with implant success and safety such as revision rates, infection rates, quality of life measures (i.e. Harris Hip Scores, improvement in activities of daily living, etc). 2) Develop a mechanism for CDRH to analyze or receive specified analyses related to safety and effectiveness of artificial joints such as: Collaboration with doctoral students, academic institutions, medical centers, etc. to jointly conduct analyses; access to data through a secure web portal where CDRH epidemiologists can perform their own epidemiological analyses; conduct of analyses on a per-request basis. 3) Develop, collaborate and disseminate manuscripts, reports and/or presentations. METHODS: Specific information required in the registry includes: 1) All artificial joint replacements, 2) Demographic characteristics, 3) Device characteristics, 4) Survival information, 5) Revision Rates, 6) Adverse Events, and 7) Short and long term outcomes. Access to data analysis through web portal or requests of specific data analysis or collaboration with a designated individual within the country who will work with CDRH to conduct any of the following: Survival analysis of length of the duration of implant; Evaluation of adverse events and relatedness to the device; Evaluation of revision rates. Reporting Requirements and Deliverables - The successful contractor will be required to submit the following items: 1. A proposed mechanism for CDRH to analyze or receive specified analysis related to safety and effectiveness of artificial joints such as: • Collaboration with doctoral students, academic institutions, medical centers, etc. to jointly conduct analyses (i.e. the in-country designee may have sole access and conduct analyses in collaboration with the CDRH designee); • Access to data through a secure web portal where CDRH epidemiologists can perform their own epidemiological analyses; • Conduct of analyses on a per-request basis. 2. Development of an agreement based on the proposed mechanism. 3. Access to data analysis through web portal or requests of specific data analysis or collaboration with a designated individual within the country who will work with CDRH to conduct the following: • Survival analysis of length of the duration of implant related to revision rates, infection rates and other indications of adverse events or device effectiveness; • Evaluation of adverse events and relatedness to the device; • Evaluation of revision rates. 4. Development of a report or manuscript that has the potential to be published. The results of this project will be disseminated to all interested parties in the FDA and to the participating institutions within the registry. They will also be presented at national and international orthopedic meetings and prepared for publication in peer-reviewed journals as agreed upon between CDRH and the contractor. Period of Performance: May 1, 2009 through May 31, 2010. An official authorized to bind the Offeror must sign the terms and conditions of the offer. Offerors that fail to furnish required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. Contract type: Commercial Item - Firm fixed price. Simplified acquisition procedures will be utilized. FOB Point: Deliverables shall be submitted to: Food and Drug Administration, CDRH, 1350 Piccard Drive, Rockville MD 20850. The provision at FAR 52.212-1 Instructions to Offerors – Commercial Items applies to this solicitation. The following addenda have been attached to this provision: None. The provision at FAR 52.212-2 Evaluation – Commercial Items is applicable to this solicitation. The specific evaluation criteria to be included in paragraph (1) of that provision are as follows: (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers: Technical, Price and Past Performance. Technical and past performances, when combined, are equal to price. The technical quotations will receive paramount consideration over cost and past performance; however, cost will be evaluated for price reasonableness. Each offeror must (1) submit written information that pertains to their capability to perform the required study, (2) identify two sources for which the offeror has provided the same or similar services that are required herein (include contracts within the past two years, Points of contact and telephone numbers). The Government may make its decision on the basis of initial quotations received and not have discussions. Therefore, each initial quotation should contain the offeror’s best terms from both a price and technical standpoint. Offerors shall include technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum required item, which demonstrates the capabilities of the offeror. The Government is not responsible for locating or securing any information, which is not identified in the proposal. Before the offer’s specified expiration time, the Government may accept the offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The government will award a contract to the offeror whose offer conforms to this solicitation and will be most advantageous to the government, price and other factors considered. The government reserves the right to make an award without discussions. Offerors must include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications – Commercial Items with its offer. If the end product(s) offered is other than domestic end product(s) as defined in the clause entitled “Buy American Act-Supplies,” the offeror shall so state and shall list the country of origin. The clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition. The following addenda have been attached to the clause: None. The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.222-3; 52.222-19; 52.222-21; 52.222-26; 52.222-36; 52.225-1; 52.225-3 Alt II, 52.225-13 and 52.232-33. Clauses and provisions can be obtained at http://www.acquisition.gov. CCR Requirement- Offeror’s must be registered in the Central Contractor Registration (CCR) before an award can be made. If offeror’s are not registered in CCR, they may do so by accessing the CCR website at: http://www.ccr.gov. A standard commercial warranty on parts and workmanship is required. The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable to this solicitation notice. All responsible sources may submit a quotation, which if timely received, shall be considered by the agency. The quotation must reference solicitation number 09-222-SOL-00006. The Offers are due in person, by email, fax or postal mail on or before April 14, 2009 by 1:00 p.m. (Central Time – Local Prevailing Time in Jefferson, Arkansas), at Food and Drug Administration, OC/OSS/OFFAS, Attn: Regina Williams, 3900 NCTR Road, HFT-320, Jefferson, AR 72079-9502. For information regarding this solicitation, please contact Regina Williams @ (870) 543-7012, FAX (870) 543-7990, email: regina.williams@fda.hhs.gov.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=4a5d338250db762a7af5d0b92907269d&tab=core&_cview=1)
- Place of Performance
- Address: Food and Drug Administration/Center for Devices and Radiological Health, 1350 Piccard Drive, Rockville, Maryland, 20850, United States
- Zip Code: 20850
- Zip Code: 20850
- Record
- SN01782154-W 20090402/090331222036-4a5d338250db762a7af5d0b92907269d (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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